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Recent Insider Buying Activity at BioSig

03/23/2018


OTC:BSGM

In the last 3 months there have been 18 Open Market Buys recorded with the SEC regarding Insider Activity for BioSig Technologies (OTC:BSGM). 

Director Patrick Joseph Gallagher bought 20,000 shares of BioSig Technologies stock in a transaction dated Friday, March 9th. The shares were acquired at an average cost of $1.40 per share, for a total transaction of $28,000.00. The transaction was disclosed in a document filed with the Securities & Exchange Commission. 

Director Andrew Lawrence Filler acquired 14,518 shares of the company’s stock in a transaction on Monday, March 19th. The shares were purchased at an average cost of $1.45 per share, with a total value of $21,051.10. 

Other shares have been purchased by Directors and Officers at a consistent pace over the past 12 months with a decided increase in March of 2018. This includes shares purchased by Founder Kenneth Londoner, and Officer Patrick Gallagher. As the company heads into their upcoming 501(k) submission and anticipated news of its clearance, the leadership is sending clear signals that the company is on track. 



BioSig is a medical device company that is developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace. In 2017, BioSig was focused on preparing the 510(k) submission for FDA clearance.  The company currently plans to receive clearance in the first half of 2018.  

Since PURE EP is not implanted in the body, and is not life sustaining, it represents moderate risk, and is characterized as a Class II medical device.  Class II devices follow the 510(k) clearance process and do not require clinical data to gain FDA approval.  Generally speaking, Class ll devices are cleared in five to six months, which puts BioSig on track per their business plan.

The recent increase in share ownership indicates that the Los Angeles-based BioSig Technologies believes it is on the right path to commercialize its first product, the PURE EP(TM) System.  

To accelerate their development progress, BioSig has partnered with Minnetronix on technology and manufacturing. Their collaboration with Minnetronix is designed to develop the PURE EP system, accelerate FDA clearance and scale the ability to manufacture the device.  Minnetronix is a medical technology company that specializes in electronic and electromechanical devices with a successful 20 year history.  A main benefit to this relationship is the regulatory experience with many other products developed by Minnetronix that will be an asset for developing PURE EP.

The company has also recently announced a newly formed Advisory Board to augment their existing Board of Directors and Scientific Advisory Board.  The first members of this new Advisory Board include Kent Williams, CEO and Principal of Vista Asset Management, LLC and Executive Advisor to Sherpa Technology Group, and Dr. Ramachandra Malya, M.D., a Medical Director and leading nephrologist. The company’s scientific advisory board includes seven electrophysiologists who from leading hospitals in Florida, Texas, California, New York, Ohio and Michigan. Several of the board members have been involved in testing the product and providing insights from their practices. 

BioSig was founded in 2009 and is the vision of ex-investment portfolio manager Ken Londoner who saw the need for next generation medical devices in the cardiovascular space.  The company’s first (and to date only) product is based on frontline insights from electrophysiologists who performed ablative procedures for atrial fibrillation.  Londoner learned that a primary obstacle to their work is the interference present in electrocardiograms.  This interference causes complications that distort the quality of the images.   

In heart studies, interference from other equipment often distorts the data and quality of the readouts, deteriorating signal quality.  The more precise the data the shorter the procedure. However, if there is distortion, there is also potential misdiagnosis based on poor inputs that often results in  and the need for additional procedures.  The PURE EP system is designed to improve the quality of cardiac readings for these procedures by employing signal processing tools to reduce the interference.
 
This novel cardiac signal acquisition and display system will help electrophysiologists diagnose and treat patients with abnormal heart rates and rhythms. The product is designed to improve catheter ablation treatments for Atrial Fibrillation and Ventricular Tachycardia by providing more accurate data. 

Competitors include GE’s CardioLab and St. Jude’s EP-Workmate. In early tests, PURE EP outperforms these units with a higher bandwidth range, and 2-times the sampling rate from their 24-bit vs. a 12-bit analog to digital converter. This improves both the quality and accuracy of the original signal from the PURE EP.

Growth Projections

The CDC, NIH National Heart Lung and Blood Institute and the American Heart Association, have stated that AF sufferers number from 2.7 to 6 million persons in the United States and results in over 750,000 hospitalizations and 130,000 deaths.  There are 600,000 new cases of AF each year.  Also, statistics show there are between 300,000 to 450,000 deaths due to VT every year in the United States.

BioSig reports that there are 3,000 electrophysiology labs in the U.S. and 1,500 outside the U.S.  As ablative procedures are anticipated to grow double digits, continued lab growth is also projected. 

According to earlier Zacks research, “BioSig has built an impressive reputation through its preclinical and clinical testing of the PURE EP system.  They have teamed up with leading cardiac centers for proof of concept testing, development and validation studies and clinical trials including the Texas Cardiac Arrhythmia Institute, UCLA Cardiac Arrhythmia Center, U.H. Case Medical Center, William Beaumont Hospital, Mount Sinai Medical Center, and the world renowned Mayo Clinic”.

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